The main purpose of this study is to gather information regarding the safety of ReFacto AF, and how well it works (effectiveness) in male patients with severe Hemophilia A =12 years of age.

• Conditions: Severe haemophilia A (FVIII:C <1%) in male patients =12 years of age with a treatment history of >150 EDs to prior recombinant or plasma-derived FVIII replacement products and transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products; MedDRA version: 14.1Level: LLTClassification code 10018937Term: Haemophilia ASystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2008-007997-39-AT
• Lead Sponsor: Wyeth Pharmaceuticals, Inc. Acting through its division Wyeth Research, a Pfizer Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-24
• Last Update Posted: 29 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

1. Male patients =12 years of age with severe hemophilia A (FVIII:C <1%).
2. Treatment history of >150 EDs to prior recombinant or plasma-derived FVIII replacement products.
3. Transitioning to ReFacto AF from ReFacto or other recombinant or plasma-derived FVIII replacement products.
4. Albumin = the lower limit of normal (LLN).
5. Platelet count =100,000/µL.
6. Prothrombin time (PT) =1.25 × ULN, or international normalized ratio (INR) =1.5
7. Documented HIV-positive patients must have CD4 count >200/µL and HIV viral load <200 particles/µL confirmed within 6 months prior to enrollment.
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1. Presence of any bleeding disorder in addition to hemophilia A.
2. For laboratory assessment, any measured Bethesda inhibitor titer =0.6 BU, regardless of the laboratory normal range, or any Bethesda inhibitor titer >ULN for the testing laboratory at the time of screening.
3. Treated with immunomodulatory therapy (including Immune Tolerance Induction [ITI]) during the screening period.
4. Prior exposure to moroctocog alfa (AF-CC).
5. Treatment with any investigational agent or device within 30 days before the Enrollment visit.
6. Known hypersensitivity to hamster protein.
7. Any condition(s) that compromises the patient’s ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation (these conditions include, but are not limited to, inadequate medical history to assure study eligibility; inability to properly store study drug; expectation of poor compliance in study-related documentation).
8. Unwilling or unable to follow the terms of the protocol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified